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Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA

13. januar 2016 opdateret af: Sabrina Müller, Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data

The central questions of the study can be summarized as follows:

What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months.

Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.

The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

204464

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The analysis is based on a data set of patients with atrial fibrillation (01/01/2010 - 30/06/2014) insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg.

Beskrivelse

Inclusion Criteria:

  • one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters
  • Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg

Exclusion Criteria:

  • Age < 18 years
  • Maximum possible observational period < 12 months (exception: death)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
No anticoagulation with VKA/NOAC
No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days.
Anticoagulation with vitamin-k-antagonists
The patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year). The patient should be not been around on other anticoagulants during the observation period. This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year.
Medicin: vitamin-k-antagonists
Anticoagulation with novel oral anticoagulants
The patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year). This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period.
Medicin: Novel oral anticoagulants

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Death
Tidsramme: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
01/01/2011-30/06/2014; at least 12 months; up to 40 months
Transient ischemic attack
Tidsramme: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
01/01/2011-30/06/2014; at least 12 months; up to 40 months
Ischemic stroke
Tidsramme: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
01/01/2011-30/06/2014; at least 12 months; up to 40 months
Hemorrhagic stroke
Tidsramme: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
01/01/2011-30/06/2014; at least 12 months; up to 40 months
Heavy bleeding
Tidsramme: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
01/01/2011-30/06/2014; at least 12 months; up to 40 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

11. januar 2016

Først indsendt, der opfyldte QC-kriterier

13. januar 2016

Først opslået (Skøn)

18. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NOAC001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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